research coordinator training -...

ORACLE® RDC ONSITERESEARCH COORDINATOR TRAINING

RDC system training is designed and conducted for access to OnSite.

Additional RDC training will be provided on a per study basis by designated sponsor personnel as needed.

Previous RDC training cannot be substituted and/or extended to other personnel on sponsor’s behalf.

Trainees must complete all applicable sections.

Once all required training has been completed, training documentation and user account information will be provided by sponsor.

TRAINING REQUIREMENTS

Oracle RDC OnSite Training v7.0 | April 12, 2017 | Medtronic Confidential

AGENDA

Key Topics: Login Process System Overview Data Entry Discrepancy Management eSignatures Reports


REFERENCE: DEFINITIONS

RDC: Remote Data Capture, which is a synonym for EDC, or Electronic Data Capture. RDC OnSite is Oracle’s version of an EDC system.

Casebook: The set of CRFs to be collected at various visits for each patient. Also known as a Data Collection Instrument (DCI) Book.

Discrepancy: CRF data that have been flagged as being suspect (illogical, inconsistent, or implausible). Discrepancies can be univariate (single-field) or multivariate (multi-field). Discrepancies may be auto-generated by the system or manually created by a user.

Verify: RDC terminology meaning “to monitor”. Verified means monitored, i.e. source document verified.


LOGIN PROCESS

SITE LOGIN PROCESS:

Use Internet Explorer and enter the following URL: https://edc.medtronic.com/

(Bookmark this site)

Click the Change password link

Enter your User ID and click Next


SITE LOGIN PROCESS:

The system will send you a new, temporary password via email from [email protected] or [email protected](depending on geography)

If your email address changes contact sponsor

Click on the Return to login screen


SITE LOGIN PROCESS:

Enter your Username and temporary password

Enter the temporary password in current password field

Enter a new password in the new password and again in confirm new password fields

Click Change Password

Click Continue on the next screen

Close Internet Explorer and open a new Internet Explorer window

Log into RDC with the new password



SITE LOGIN PROCESS: ACCESS TO MULTIPLE STUDIES

If you have access to more than one study, the following page will display.

If a user has access to only one study, this page will not display and RDC will open automatically from the LOGIN button.

Selecting a study from the drop-down and clicking Submit will open RDC to that study.


LOGIN PROCESS: BROWSER COMPATIBILITY CHECK

If you attempt to login with an unsupported browser, the following screen will display. You will need to close the window and open with a supported browser.


LOGIN PROCESS: COMPATIBILITY SETTINGS CHECK

If you do not have the proper browser compatibility settings in place, you will receive the following message with instructions on updating the compatibility settings.

LOGIN PROCESS: PASSWORD RULES

The password cannot be the same as the User ID (Username)

Passwords are case sensitive The first character in a Password must be an alpha character

Passwords cannot start with a numeric value or a punctuation mark

Passwords must be at least 7 and no more than 15 characters in length

Passwords must contain at least one numeric character

Passwords must contain at least one uppercase character

Passwords must contain at least one lowercase character

Passwords may not contain any of the following special characters:

! @ % ^ & * ( ) - + = { } [ ] | \ : ; " ' < > , . ? / ~ ` # $ _ A password cannot be reused until the password has been changed at least 10 times

The system may reject passwords that are too similar (e.g., if you change Coffee1 to Coffee2)


LOGIN PROCESS: PASSWORD REMINDERS

If your login fails 3 consecutive times due to the entry of an incorrect password, the system will lock your account Wait 10-15 minutes and try to login again

If you are still unable to login, contact Medtronic

Passwords expire after 6 months for external users. The system will notify the user when they log in that a password is

going to expire soon, or if it has expired

An account with an expired password will be enabled again upon resetting the password

Research Coordinators and Investigators each receive their own accounts

Do NOT share your password with anyone as it is equivalent to your electronic signature

Do NOT use another person’s account to log in


SYSTEM OVERVIEW

SYSTEM OVERVIEW: GLOBAL LINKS

Global Links Logout: Ends the RDC session

Help: General RDC help system, not specific to the study protocol


SYSTEM OVERVIEW: TABS

Tabs Home: Main screen where patients are

selected

Patient Casebooks: Where data entry occurs

Review: Where data review occurs

Reports: Where reports are run


SYSTEM OVERVIEW: STUDY AND SITE SELECTION

Study and Site selection The first dropdown lists studies you have access to

The second dropdown lists investigational sites you have access to

After selecting study and site, the system automatically updates the patient list


SYSTEM OVERVIEW: STUDY AND SITE SUMMARY

Display window:

Summarizes all sites in the study the user can access and high level study information

Summarizes information in the selected site

Clicking Study and Site Summary opens a display window


SYSTEM OVERVIEW: SECTIONS

News: Can be used to share study specific information such as study milestones

Activities: Displays links to tasks specific to the user role such as discrepancy review, CRFs ready for initial verification, CRFs ready for initial approval, or Investigator Comments

Links: Displays external links specific to the study such as an electronic diary website


Click on the small arrow to expand or collapse this pane

SYSTEM OVERVIEW: SECTIONS

Activities: Use the Review Non-blank CRFs… links with caution – Pre-filters are set with only some forms selected

For example: Review non-blank CRFs ready for initial approval contains CRFs with no discrepancies and are verified.

The Review tab at the top left of the page can be used in place of these links to ensure all forms of interest are included in the filter.


SYSTEM OVERVIEW: LIST OF PATIENTS

List of Patients Patient Search: Expand

to search for patients with specific criteria

Patients: Lists all patients assigned to the site, unless filtered using the Patient Search criteria


SYSTEM OVERVIEW: PATIENT SUMMARY

Click on a patient icon to display a patient summary

Icon Descriptions:

Patient has no discrepancies

Patient has at least 1 active discrepancy, i.e. for the user role logged in

Patient has other discrepancies, i.e. for another user role

No data entered for patient


DATA ENTRY

DATA ENTRY: PATIENT SELECTION

1. Select patient(s) whose data will be viewed, entered or updated. Multiple patients can be selected using Ctrl or Shift + Click.

Start data entry on a new patient or add a new CRF for an existing patient.

2. In the Action menu, select Multi-Patient View or Single Patient View



SINGLE PATIENT VS. MULTI-PATIENT VIEW

Single Patient View Allows the user to view all CRFs for a patient at one time instead of needing to change

between Visits

Visits are displayed within the leftmost column

If multiple patients are selected using this view, you can use the navigation arrows to display the next patient

Multi-Patient View Allows the user to see CRFs within a particular visit across multiple selected patients

User can change visits using the Visit drop-down

Note: after selecting patients and a view, you can change between views using the View drop-down menu

DATA ENTRY: SINGLE PATIENT VIEW

Use the arrows to navigate between patients (if multiple selected)

Each row is a visit and their associated CRFs

Each cell contains a unique CRF for that particular visit in the selected patient

Change View

(Single or Multi-Patient)


Links in Patient Summary section can be used to filter day (e.g., only show CRFs with open discrepancies)

DATA ENTRY: MULTI-PATIENT VIEW

Visit Selection

Each row is a patient and their CRFs

Each column is a CRF number

Each cell contains a unique CRF for that particular patient in the selected visit

Change View

(Single or Multi-Patient)


Switching to Multi-Patient View brings up additional options in the Search menu

DATA ENTRY: CRF ICON DESCRIPTIONS

CRF Entry StatusAvailable for entry

Marked blank

Entry started (Saved Incomplete)*

Entry complete (Saved Complete – no discrepancies)

Batch loaded data

Discrepancy StatusActive (at least 1 discrepancy for the user role logged-in)

Other (all discrepancies are for a different user role)

Approval and Verification StatusVerified Requires re-verification

Approved Requires re-approval

Multiple statuses may be displayed. For example, a CRF can show a discrepancy, require re-approval and re-verification.

*Not applicable for Legacy Covidien studies or new studies in the Standard Database (MTOPA)


DATA ENTRY: ENTERING A NEW CRF

An icon with a blank page and green arrow means a CRF is available for data entry

Click the icon to begin data entry, or click any other icon to edit an existing CRF


DATA ENTRY: DATA ENTRY WINDOW

CRF Entry

Toolbar

Discrepancy

Navigator

PaneAudit History Pane


DATA ENTRY: TOOLBAR

Close CRF

Add Discrepancy

Next and Previous CRFs in the Visit

Add Investigator Comment**Not enabled in all databases

Delete

Row

Verification History

Approval

History

Save

Dropdown to control the highlighting of data entry fields

Delete

CRF

Generate CRF

History

Blank Flag ToolCustom Review

History

Generate

CRF Report


DATA ENTRY: ENTERING DATA

Header

List of Values with drop down list -identified by the magnifying glass icon

Date fields - enter directly or click calendar icon (DD-MMM-YYYY)

T: enters today’s dateY: enters yesterday’s date

If a date is unknown, consult study specific training or study team member

List of Values with Checkboxes - click the choice or tab and press space bar (check all that apply)

Body - Data entered here

List of Values with Radio Button -click on choice or tab and press space bar (select only one)


DATA ENTRY: INVESTIGATOR COMMENTS

Note: Investigator Comment functionality is not enabled for Legacy Covidien studies or new studies in the Standard Database (MTOPA)

Use this feature when you want to add a comment to a specific data field in the CRF

These are reviewed by the sponsor but not responded to Example: “Medication start date may be off by a couple days”

Do not enter any subject data as an Investigator Comment


DATA ENTRY: ADDING INVESTIGATOR COMMENTS

3. In the popup window, enter the comment and click OK.

2. Click the Investigator Commenticon in the toolbar.*

1. Click on the field that will receive the comment.


*If working in a database without this functionality enabled, the icon will be greyed out for site users

DATA ENTRY: VIEWING/EDITING INVESTIGATOR COMMENTS

In the Highlight dropdown, select Investigator Comments.

All fields with investigator comments will be highlighted in purple.



In the popup window, edit the comment and click OK, or view the comment and click Cancel.

Right-click the data field, and select Investigator Comment.


To view details, select desired data field from the available List section.

Details of selected comment will be displayed in the Details section below.

The investigator comment can also be viewed in the Navigator pane.



DATA ENTRY: SAVING THE CRF

1. Click the Save icon in the toolbar.

2. Click either:– Save Complete if all

data have been entered

– Save Incomplete if additional data will be entered later *

*Not applicable for Legacy Covidienstudies or new studies in the Standard Database (MTOPA)


DATA ENTRY: NOTES ABOUT SAVING

Saving Complete may cause additional discrepancies to display. These are multivariate discrepancies which validate across multiple data fields

All changes made to data after Saving Complete will be maintained in the system’s audit trail for further reference

Saving Incomplete* will not cause additional discrepancies to be created

Changes made to data after Saving Incomplete* will not be maintained in the system’s audit trail until Saving Complete is selected

Save your work often!!! The system times out after 30 minutes of inactivity, and you will not be warned of a pending timeout!

*Not applicable for Legacy Covidien studies or new studies in the Standard Database (MTOPA)


DATA ENTRY: CLOSING THE CRF

Click this button to close the CRF.


OnSite will allow you to view, enter and/or update up to three CRFs simultaneously

If you try to open a CRF you currently have open you will get the following message:

If you select Release Lock and close the original CRF a fatal error message will appear when closing.

Click OK to close the CRF. The OnSite session will not end.

DATA ENTRY: VIEWING CRFS


If you try to open a CRF that another user has open, the CRF will open in browse mode.

DATA ENTRY: VIEWING IN BROWSE MODE


DATA ENTRY: CHANGING DATA

Changes to data after the CRF is Saved Complete will be maintained in the system’s audit trail for further reference.

1. Change the data.

2. A popup window will appear requesting a reason and an optional comment.

3. Click OK.

4. Save the CRF.


DATA ENTRY: VIEWING AUDIT HISTORY

In the Highlight dropdown, select Audit History.

All fields with an audit history will be highlighted in blue.

Click this arrow to show audit history details.


DATA ENTRY: AUDIT HISTORY DETAILS

Click on a field to display the audit history below.

There will be 1 row for each change to the selected data field.

Click the Details icon for an expanded view.


DATA ENTRY: DELETING A CRF

2. A popup window will ask for a change reason and an optional change comment.

3. Confirm that this CRF really should be deleted.

1. Open the CRF to be deleted and click the Delete CRF icon.


3. Provide the reason for change when prompted.

If all data in a row should be removed, the delete row feature should be used. Deleting an individual field will generate discrepancies for missing data.

1. Click anywhere in the row that you want to delete.

2. Click on Delete Row Icon or Right Click and choose Delete Row.

DATA ENTRY: DELETING A ROW


DATA ENTRY: PERMANENTLY MISSING CRFS

There are situations where protocol-planned CRFs may never be available. For example, a patient may be unable to complete a Follow-up Visit due to unusual circumstances.

When any planned/required CRF will not be collected:

A Protocol Deviation Form should be completed

The missing CRF should be entered in the database with a blank flag, if required for the study


DATA ENTRY: MARKING A CRF AS BLANK

3. Check all boxes and click OK.

If applicable for the study, mark the “Is Blank” checkbox instead of using the Blank Flag Tool.

1. Open the CRF that will be marked blank.

2. Click the Blank FlagTool icon to display the popup window.


DATA ENTRY: MARKING A CRF AS BLANK (CONT.)

All data fields will now be grayed out. Save and close this CRF. It is now marked as “blank” and will appear in the casebook grid with a blank icon.


DATA ENTRY: REVERSING A BLANK FLAG

2. Uncheck all checkboxes, and click OK. This will make the data fields enterable again.

1. To remove the blank flag, click the Blank Flag Toolicon to display the popup window.

If applicable for the study, uncheck the “Is Blank” checkbox to enter data.

A CRF or sections of a CRF could also be automatically marked as blank if it is Saved Complete, but no data have been entered.


2. Select a patient (only one).

1. Select the visit.

3. Click appropriate button.

DATA ENTRY: UNPLANNED CRFS

Add Visit Page or Add Other Page are used to collect unplanned CRFs. Refer to study materials for further guidance on when these functions should be used and for the applicable CRFs.


Add Visit Page: the only CRFs that are available in the list are ones associated with the selected Visit (e.g., Event). To add other types of CRFs, use the Add Other Page.

Add Other Page: CRFs that are not associated with the selected Visit will display in the list. You cant add a new Visit Page until at least one of the pre-populated CRFs has data on it.

5. In the new popup, select the next available number for the visit.

6. Click on the Entry Expected Icon to enter data.

4. From the popup, select the CRF and click Continue.

DATA ENTRY: UNPLANNED CRFS (CONT.)


Additional visits will have Sub-visit numbers

The first visit is always visit 0. Additional visits are displayed with the CRF name followed by the Sub-visit number.

The Sub-visit number is also displayed on the top of the CRF.

DATA ENTRY: UNPLANNED CRFS (CONT.)


DISCREPANCY MANAGEMENT

DISCREPANCY MANAGEMENT: DISCREPANCY TYPES

Discrepancies result when data fail to pass specified validation criteria

Discrepancies can be created 3 different ways:1. Univariate: As data are entered, a discrepancy is created on that individual

field (e.g., An age of 92 is out of an expected range of 18 to 85).2. Multivariate: When a CRF is Saved Complete (either immediately after or

after a nightly batch validation), discrepancies are created that consider multiple data points (e.g., The date of a study procedure was earlier than the date informed consent was signed).

3. Manual: A discrepancy can be manually created on any section or field.


DISCREPANCY MANAGEMENT: UNIVARIATE DISCREPANCIES

As data are entered, some checks are performed on the data.

If data are discrepant, a message will appear:

• Click Cancel to make corrections to the data

• Click OK to create a discrepancy


DISCREPANCY MANAGEMENT: COLORS

Click the left arrow to expand the Navigator Pane and work with discrepancies.

Discrepancies are represented by 1 of 3 colors:Yellow: Discrepancy is active for another user role

Red: Discrepancy is active for the current user role

Green: Discrepancy has been manually closed


DISCREPANCY MANAGEMENT: NAVIGATOR PANE

Click on a discrepancy in the list.

- Univariate discrepancies are listed with the question name

- Multivariate discrepancies are listed as “Multi” since they may deal with more than one question across more than one CRF

A blue dashed box is displayed around the question.

Details are displayed in the bottom right Details pane.


DISCREPANCY MANAGEMENT: NAVIGATOR PANE (CONT.)(SITE)

Click the Update icon to update the discrepancy comment.

Click the History button to show the history of the discrepancy.

For multivariate discrepancies, click the Related Values button to see related values affected by the discrepancy.

Use the Action dropdown to route the discrepancy back to the Sponsor.


DISCREPANCY MANAGEMENT: DISCREPANCY REVIEW

1. Click the Review tab.

2. Click the Discrepancies sub-tab.

3. Set the Discrepancy Status filter to Active.

4. Click Search.

A list of ALL your Active discrepancies will be displayed.


DISCREPANCY MANAGEMENT: DISCREPANCY REVIEW (CONT.)

Click the CRF icon to open the CRF and work on the discrepancy.

If available, click the Detail icon to display details about the discrepancy.


DISCREPANCY MANAGEMENT: SUMMARY - RESOLVING DISCREPANCIES (SITE)

1. Review the discrepancy in the Navigator Pane.2. Update the data on the CRF (if necessary) and save the changes.3. If the discrepancy does not automatically close or if the data on the

CRF does not need to be updated, route the discrepancy to the sponsor with a comment to indicate the status of the discrepancy (e.g., data updated or Event form added).


1. From the casebook tab select the subjects to validate.

2. Select the Validateoption in the Action dropdown.

Validation can be run on one or more subjects from the casebook tab. The option is only available to roles with update access in OnSite.

Some discrepancies will not fire until a patient's data have been validated. This occurs automatically once per day; however a user may force validation on their own.

DISCREPANCY MANAGEMENT: VALIDATION FUNCTION


DISCREPANCY MANAGEMENT: VALIDATION FUNCTION (CONT.)

3. A pop-up box will appear.

4. Click Continue to start validation.

5. A confirmation window will appear when validation is complete.


ESIGNATURES

Verified means monitored in RDC terminology (i.e. source document verified)

Only Study Monitors have the capability to verify CRFs

If data changes or discrepancies are added or closed on a verified CRF, the form will require re-verification

ESIGNATURES: MONITOR VERIFICATION


ESIGNATURES: INVESTIGATOR APPROVAL

An approval is a 21 CFR Part 11 electronic signature. It is the equivalent of a handwritten signature on a paper CRF

Only investigators have the capability to approve CRFs

Coordinators cannot approve CRFs on the Investigator’s behalf

CRFs can be approved 2 ways: Individual Approval: Each CRF is opened and approved Group Approval: After reviewing a batch of CRFs you may approve them at

the same time

Regardless of the method used to approve, the Investigator is responsible for the data submitted and required to approve each CRF

Note: If you have just changed your password, log out of RDC and repeat login using the new password before approving any CRFs. This will ensure the new password is in effect during the Approval process.


REPORTS

REPORTS: TYPES

Two types of reports are available: Patient Data Report: Creates a PDF file containing all or selected CRFs entered for a

patient(s). The data fields are populated with values entered for the CRFs. This report may be useful for investigator review of hardcopy CRFs, or for an FDA audit where patient data has been requested.

Blank Casebook Report: Creates a PDF file containing all the CRFs that may be collected during the study. This may be useful for creating source doc worksheets, or for becoming familiar with the CRFs at the start of the study.

Note: Patient Data Reports may be generated from the Home, Casebook, Review or Reports tabs. Blank Casebook Reports may be generated from the Reports tab only.


2. Search by patient.

4. From the drop-down, select “Generate Patient Data Report” and click GO.

1. Click the Patient Casebooks tab.

3. Select the patient(s) you want to include in the report.

REPORTS: GENERATING ALL DATA ENTERED FOR PATIENT(S)


A message will indicate the report is being created.

To access the report select the Reports tab.

REPORTS: GENERATING ALL DATA ENTERED FOR PATIENT(S)


4. From the Action drop-down, select “Generate Patient Data Report”

2. Search by patient.

3. Select the CRFs you want to include in the report.

1. Click the Review tab.

REPORTS: GENERATING SINGLE CRF DATA


To access the report select the Reports tab.

A message will indicate the report is being created.

REPORTS: GENERATING SINGLE CRF DATA (CONT.)



REPORTS: SINGLE-CLICK PDR BUTTONS (INDIVIDUAL CRF)

Patient Data Reports can be generated within an individual CRF Generate CRF Report: generates a standard Patient Data Report for the opened

CRF

Generate CRF History: generates a report of the audit history for the opened CRF

1. Select either the “Generate CRF Report” or “Generate CRF History” icon as desired

2. Once the report generates, a new icon will appear. Click this icon to download the report.3. In the dialog window that

appears at the bottom of the screen, select Open or Save.

REPORTS: PATIENT DATA REPORT EXAMPLE

Report contains bookmarks for easy navigation.

Printing a PDR from the Reports tab will result in all CRFs.

Printing a PDR from the Review tab allows you to select specific CRFs.


REPORTS: GENERATING BLANK CASEBOOK

2. Click on New Blank Casebook Report.

1. Click the Reports tab.

A Patient Data Report can also be requested from the Review tab.


REPORTS: GENERATING BLANK CASEBOOK (CONT.)

4. Then click Submit Job.

3. Select from the various report parameters.

Blank Casebook report

Patient Data report



A message will indicate the report is being created. It may take 10 – 15 minutes for large reports.

5. Click Yes when prompted.

A red stoplight icon indicates the report is still being created. Clicking it will stop the report.



6. Click the link to open the report.

When the report is complete, the stoplight icon will disappear and the status will indicate success.


REPORTS: BLANK CASEBOOK REPORT EXAMPLE

Report contains:

• All CRFs for all visits, including unplanned

• Bookmarks for easy navigation.


TIPS AND TRICKS

TIPS AND TRICKS: WINDOW SIZE TOO SMALL

If any window, for example a CRF window, opens too small and you would like it to always open larger:

1. Close all Internet Explorer windows.

2. Open one Internet Explorer window.

3. Set the size of this window to the desired size when future windows are opened.

4. While pressing the Shift key, click the “X” in the upper right-hand corner of the window to close it.

Next time an Internet Explorer window is opened, it will default to this new size.


TIPS AND TRICKS: HOT KEYS

Alt + P: Moves to previous CRF

Alt + N: Moves to next CRF

Alt + S: Saves the CRF

Ctrl + W: Closes CRF

In date fields: T: enters today’s date Y: enters yesterday’s date

Tab: moves to the next field on a CRF

Shift Tab: moves to the previous field on a CRF

Alt + Tab: Allows you to toggle between applications.


research coordinator training -...

Documents